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ProteIn Nutrition in Crohn's Disease

NCT05572008 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-10-07

No results posted yet for this study

Summary

Muscles are essential for good quality of life. The investigators have shown that when children with Crohn's disease eat protein, only very little of it enters the muscles, leading to poor muscle growth and fatigue. The investigators want to find the reasons for this. The investigators will recruit 20 Crohn's disease patients and a matched group of healthy kids. The investigators will measure:

* Daily food intake and muscle strength.
* Protein absorption by giving our participants a milk protein test drink and take regular blood samples after.
* Muscle mass with MRI. This study will help understand how protein is handled in these patients.

Conditions

  • Crohn Disease

Interventions

BEHAVIORAL

Protein nutrition in paediatric Crohn's disease

All participants (N = 40) will undergo the same study procedures: Eating behaviour questionnaire(s) completion Duration: 5 minutes Frequency 2 Dietary intake data via online computerised recall Duration: 60 minutes Frequency: 3 Collection of blood sample via venepuncture Duration: 15 minutes Frequency 1 Strength Tests Duration: 30 minutes Frequency: 1 Half the participants (N = 20) will return for two more visits and will undergo the following procedures: MRI Scan Duration: 30 minutes Frequency: 1 Consumption of intrinsically labelled protein Duration: 15 minutes Frequency: 1 Insertion of cannulae into hand Duration: 15 minutes Frequency: 1 Collection of blood sample via cannulae (for protein digestion and inflammatory markers and study endpoints outlined below) Duration: 1 minute Frequency: 17

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Gordon Moran, PhD · University of Nottingham

  • Kostas Tsintzas, PhD · University of Nottingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2022-12-28
Completion
2023-05-25

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05572008 on ClinicalTrials.gov